Albert Science International Organization

ARTICLE DESCRIPTION: 

Ashish Kumar Gupta, Minakshi Verma, Preformulation Studies of Acyclovir with Special Reference to Development of Analytical Methods, Crystal Properties of Drug and Drug- Excipients Interaction Studies, ASIO Journal of Pharmaceutical & Herbal Medicines Research (ASIO-JPHMR), 2(2), 2016: 01-08.

ARTICLE TYPE: Research

dids/doi No.: 12.2015-77737978

dids link:  http://dids.info/didslink/06.2016-38182138/

ABSTRACT:

The main objective of this work was to develop the Preformulation studies of acyclovir. Preformulation study was mainly performed to develop simple, accurate, precise and cost effective UV-VIS Spectrophotometric method for the estimation of Acyclovir, an antiHIV drug, in bulk and pharmaceutical dosage form. Various parameters like melting point, pK_a, K_o/w, flow properties of the powder drug, crystal morphology, drug excipients compatibility studies and particle size distribution were carried out. The solvent used was 0.1N HCl and the λ_max or the absorption maxima of the drug was found to be 255nm. The regression co-efficient obtained from the standard plots were nearing about 1.0 and which proved the linearity of the analytical methods. Calibration curves followed the linear regression. All the models followed Beer-Lambert’s law and therefore can be analyzed by UV spectrophotometer. This method can be used for the determination of Acyclovir in quality control of formulation without interference of the excipients.

Keywords: Acyclovir, pKa, Ko/w, flow properties of the powder drug, crystal morphology, drug excipients compatibility studies and particle size distribution, UV-Vis Spectro photometry

1.  Holkar G, Daphal V. Method Validation and Quantitative Determination of Antiviral Drug: Acyclovir in Human Plasma by a LCMS/MS, Biological Forum — An International Journal, 2012; 4(1): 11-17.

2.  Pant P, Saradhi V. Spectrophotometric Determination of Acyclovir through Oxidative Coupling of with 2, 2’-Bipyridine by Horsradish peroxidase (HRP), Journal of Applied Chemical Research, 2009; 10: 7-12.

3.  Michael T. Ultraviolet & Visible Spectroscopy, 2nd ed. Wiley John & Sons Ltd., Chichester, 1996: 126-160.

4.  ICH, Q2A, Text on Validation of Analytical Procedures, International Conference on Harmonization, Geneva, October 1994: 1-5.

5.  ICH, Q2B, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, Geneva, November 1996: 1-8.

6.  Galen E. Instrumental Methods of Chemical Analysis, 5th ed, McGraw- Hill international edition, 1985: 32-51.

7.  Thomas M, Analytical Chemistry by Open Learning: Ultraviolet and Visible Spectroscopy, 2nd ed. John Wiley and Sons, 1996: 131-132.

8.  Garg G, Daharwal S. Various UV spectrophotometric Simultaneous estimation methods, www.pharmainfo.net, 2006.

9.  Ablel-Aziz Y, Sayed A. Recent Development of Derivative Spectrophotometry and their Analytical Applications, 21 ed. Analytical Sciences, 2005: 595-613.

10.   Instruction Manual Pharmaspec, UV 1800 Series, Operation Guide. Shimadzu Spectrophotometer, Shimadzu Corporation, Koyoto, Japan, 2001: 2.2-2.9; 5.16, 8.2.

11.   K.A. Connors, G.L. Amidon, and V.J. Stella. Chemical Stability of Pharmaceuticals (Second Edition), John Wiley & Sons, Inc., 1986.

12.   E.F. Fiese and T.A. Hagen, Preformulation, Chapter 8 in the Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia, 1986.

13.   M. Gibson, Pharmaceutical Preformulation and Formulation, HIS Health Group, Englewood, CO, 2001.

14.   D.J.W. Grant and T. Higuchi, Solubility Behavior of Organic Compounds, John Wiley & Sons, Inc., 1990.

15.   L.F. Huang and W.Q. Tong, Impact of solid state properties on developability assessment of drug candidates, Advanced Drug Delivery Review, 56 (321-334), 2004

16.   W.Q. Tong, Preformulation Aspects of Insoluble Compounds, in Water Insoluble Drug Formulation, Edited by R. Liu, Interpharm Press, 2000.

17.   J. Wells, Pharmaceutical Preformulation, Ellis Horwood Limited, 1988.

18.   S. Yalkowsky, Solubility and Solubilization in Aqueous Media, American Chemical Society, Washington D.C. 1999.